UNDERGLOVES SURGICAL, coloured, neopr, s.u., ster., pair,6.5
STD
SMSUGLOSUNE65
Valid Article
Account code:
60210
HS Code:
401512
Last Updated on:
11/12/2024, 21:51:14
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
T01010201 - Polychloropren surgical gloves
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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UNDERGLOVES SURGICAL, coloured, neoprene, pair
Definition
Pair of sterile surgical gloves made of polychloroprene (neoprene) used to protect both patient and staff from infections transmitted through contact with the hands.
The under-glove is coloured which enables the immediate detection of perforation in the outer glove, of light colour
They are used to protect both the patient and the staff against contamination from microorganisms during a surgical intervention.
Specifications
Quality Standards Comment
Technical specifications
- Polychloroprene (neoprene), non powdered
- Protection 45 min to 1 h minimum
- Anatomically-shaped: 1 right hand and 1 left hand clearly identified in the packaging
- Dimensions double pairs of surgical gloves
| Size inner glove | Min. length | Width outer- inner handpalm |
| 7 | 275 mm | 85-91 ± 3 mm |
| 7.5 | 278 mm | 91-96 ± 4 mm |
| 8 | 288 mm | 95 ± 5 mm |
| 8.5 | 289 mm | 102 ± 6 mm |
| 9 | 290 mm | 108 ± 6 mm |
- Outer glove is a half size smaller than the inner glove because of:
- a better comfort: the pressure is lowered when having a bigger under glove (inner)
- a better adhesion gives a good visibility in case of perforation of the glove during the intervention
- Thickness:
- Finger: 0.19-0.24 mm
- Palm : 0.19-0.27 mm
- Cuff: 0.16-0.20 mm
- Cuff with rolled edges
- Coated inner surface (polymere, polyurethane, silicone, …)
- Textured of micro-textured external surface
- Coloured: green, blue ...
- Sterile, for single use
Packaging & Labelling
Sterile packaging in peel-open pack, per pair
The gloves are presented in a field, the sleeves reversed up to the thumb to allow aseptic extraction, with identification of right hand and left hand.
The labelling must carry the following information:
- "(product) containing natural rubber latex which may provoke allergic reactions, such as anaphylactic shock "
- "non powdered glove"
Instructions for use
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Precautions for Use
- SINGLE USE
- Wash hands before and after use of gloves
- To be worn only on dry hands
- Discard defective or deteriorated gloves.
- Remove and replace gloves which are damaged while in use
- Carefully follow undressing procedure when gloves are removed
- In case of allergy to latex, order latex-free gloves (see related articles)
Storage
- Store below 30°C, Protect from sunlight ‐ Protect from humidity
- In the original packaging
MSF requirements
- In case of allergy to latex
- Non powdered gloves, allowing the use of hydroalcoholic solution as hand cleanser
- Gloves to wear under a pair of regular surgical gloves: the coloured inner gloves enables an immediate detection of the perforations.
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